A Data Model for Clinical Study Status Reports

Abstract

Status reports for clinical studies are an important tool in the successful conduct of a clinical research project. They deliver timely information to the study team that facilitates the effective management of the study. Development and implementation of these reports requires integration of information from a number of sources including clinical data, study planning data, resource data, and timelines. A model for creating a database that allows for easy generation of various types of reports for monitoring study status is defined. Once the terminology and algorithms have been defined, some examples of the use of this model in an ongoing clinical study are shown. These reports have proven useful to each member of the study team in a variety of ways.